NCT02211261|CompletedPhase 1Results

A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus

Pfizer ClinicalTrials.gov

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1 other identifier

B3501001

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2014

StartedSep 2014

CompletionJan 2017

Brief Summary

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline

Completed

Started Sep 2014

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

August 6, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

September 15, 2014

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2017

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

October 16, 2018

Completed

Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

2.4 years

First QC Date

August 6, 2014

Results QC Date

January 22, 2018

Last Update Submit

October 15, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

first in humansingle dosemultiple doseescalationsafety studyType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
Number of Participants With Dose Limiting or Intolerable Adverse Events
Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
Number of Participants With Positive Anti-drug Antibody (ADA) Result
ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer \>=1.88 was considered positive.
Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Secondary Outcomes (21)

Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Clearance (CL) of PF-06293620 (SAD Cohorts)
Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
+16 more secondary outcomes